HomeChoice Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in U.S.A.; catalog numbers 5C4471, 5C4471R, 5C4474, 5C4474R, T5C4441, T5C4441R
This recall has been terminated (originally issued July 19, 2005).
- Company
- Baxter Healthcare Renal Div
- Recall Initiated
- June 21, 2005
- Posted
- July 19, 2005
- Terminated
- December 11, 2007
- Recall Number
- Z-1018-05
- Quantity
- 52,617 units
- Firm Location
- Mc Gaw Park, IL
- Official Source
- View on FDA website ↗
Reason for Recall
The screws that secure the Power Entry Module (PEM) to the base of the HomeChoice device are not reliably grounded to the device's ground system, posing an electric shock hazard.
Distribution
Nationwide, including Puerto Rico, and internationally to Argentina, Austria, Australia, Belgium, Canada, Chile, China, Colombia, Denmark, Ecuador, France, Germany, Guatemala, Hong Kong, Ireland, India, Italy, Korea, Mexico, Malaysia, Nicaragua, the Netherlands, New Zealand, Peru, the Philippines, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, the United Kingdom, Uruguay and Venezuela.
Lot / Code Info
all serial numbers
Root Cause
Other
Action Taken
Baxter sent Urgent Device Correction letters worldwide to their customers on 6/21/05 and home patients on 6/22/05. The accounts were informed of teh risk of electrical shock from screws used to secure the Power Entry Module to the back of the HomeChoice system, and were instructed to always connect the power cord to the power entry module first, before plugging the power cord into a grounded electrical outlet. The users were advised to use caution to avoid contact the power entry module screws while powering on or powering off the device, and were informed that a new mounting bracket that providews more reliable grounding was installed in instruments processed through the Baxter service organization as of May 2005. All remaining instruments will receive the new mounting bracket by August 2006, and Baxter will contact the accounts to arrange for the upgrade. Any questions were directed to Baxter Global Technical Services at 1-800-553-6898, prompt 1.